Glabellar Frown Lines Clinical Trial
Official title:
A Phase 3b, Randomized, Double-Blind, Placebo-Controlled Study to Assess Aesthetic Improvement and Onset of QM1114-DP Treatment Effect in Subjects With Moderate to Severe Glabellar Lines
| Verified date | February 2023 |
| Source | Galderma R&D |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The objective of this study is to evaluate the aesthetic improvement and onset of QM1114-DP treatment for subjects with moderate to severe glabellar lines
| Status | Completed |
| Enrollment | 132 |
| Est. completion date | September 1, 2023 |
| Est. primary completion date | October 28, 2022 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Male or Female 18 years or older - Moderate to severe GL at maximum frown as assessed by the Investigator - Moderate to severe GL at maximum frown as assessed by the subject Exclusion Criteria: - Previous use of any botulinum toxin in facial areas within 9 months prior to study treatment - Female who is pregnant, breast feeding or intends to conceive a child during the study. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Galderma Research Site | Chapel Hill | North Carolina |
| United States | Galderma Research Site | Coral Gables | Florida |
| United States | Galderma Research Site | Homewood | Alabama |
| United States | Galderma Research Site | Hunt Valley | Maryland |
| United States | Galderma Research Site | Manhattan Beach | California |
| United States | Galderma Research Site | Omaha | Nebraska |
| United States | Galderma Research Site | Pflugerville | Texas |
| United States | Galderma Research Site | Spring | Texas |
| United States | Galderma Research Site | Vista | California |
| Lead Sponsor | Collaborator |
|---|---|
| Galderma R&D |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Responders in QM1114-DP versus Placebo using the Global Aesthetic Improvement Scale (GAIS) at maximum frown at Month 1 | Responder Rate is defined as a subject who responds at least Improved on the GAIS at maximum frown | 1 month |
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